Growing Membership at IIR’s HIX Reloaded

It's no secret-we are all in the business of making money, and health insurance exchanges offer a huge opportunity to increase membership, and therefore increase revenue. Regardless of whether or not you're planning on participating in an exchange in 2014, your bottom line will be affected by exchanges. If you're participating in an exchange, you need to continue to increase marketing efforts throughout enrollment to ensure brand recognition to increase membership.

To ensure your membership growth strategy is aligned for success, join all members of the exchange ecosystem (plans, governments, pharma, community organizations and more) at IIR's HIX Reloaded taking place November 14-15, 2013 in Baltimore. At the event, you will engage with early adopters and HIX entrants as they share first-hand experiences and insight about open enrollment and coverage expansion for January 2014.

VOTE NOW!

Want to learn more? Download our agenda.

As a member of the HIX Linkedin group, mentioned code XP1810BLOG when registering to save 15% off of the standard rate. Questions about the event? Feel free to email Kate Devery (KDevery@IIRUSA.com) or check out our homepage.

We look forward to seeing you November 14-15 in Baltimore, MD!

Cheers,
The HIX Reloaded Team

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P.S. You are invited to sign-up for our complimentary webinar on Identifying and Engaging Stakeholders in Health Reform Outreach taking place on September 18th, be sure to use priority code 00R0MK4XB when registering.

MDRP 2013: Day 3 recap

The third and final day of MDRP 2013 kicked off with opening remarks from Edward McAdam, Daiichi Sankyo and the MDRP Lifetime Achievement Award. Congratulations to the 2013 recipient, Miree Lee!

Following the award announcement, Mark Myers, Office of the Inspector General and Mel Noel, Compliance Implementation Services, led us into the first Key Note session, Veteran Affairs Pricing Compliance and Management Updates. They covered drug pricing, transferred cover drugs, and data issues. What is the best way to signify adherence to statutory requirements? Signing a master and pharmaceutical agreement. In terms of transferred covered drugs and new drugs, one of the biggest issues is lack of timely submission. The bottom line? Make sure that you file on time, manufacturers will be responsible for overchargers based on late filing.

Myers and Noel also covered the issues of placing patented drugs on FSS contracts. They explained that, in a world where covered drugs are more frequently manufactured or have API sourced in India or China, it has become impossible for VA to place many patented covered drugs on FSS contracts of MFRS trying to comply with VHCA. So what is the solution?

VA FSS managers have tried unsuccessfully to obtain a waiver from GSAs guidance to allow FSS listing of patented covered drugs that are manufactured in or have API sourced in countries that are not TAA designated countries.

Rick Zimmerer, KPMG LLP, closed out the morning session with Operational Excellence with Minimal Resources. Zimmerer discussed some important elements to successful optimization. So what are some of the key components? Make sure it's competitive, marketable, and profitable. It's also important to remember what executives are looking for - GP as a strategic function, so where do you start?

Start by defining the issue, clearly state what decisions are required. Is legal guidance required? What's the organizational, financial impact? Potential solutions to problem? Provide a recommendation and then develop a communication plan. Once you've created a tool, it's vital you provide both training and guidance to other GP professionals on how to use it. So overall, the key steps to apply for successful optimization are: record, analyze, present, decide, and communicate. 

The final session of MDRP 2013 was the Current Legal Trends Affecting Pharmaceutical Manufacturers - Manufacturers Perspective panel moderated by Connie Wilkinson, Epstein Becker Green. Panelists included Sabrina Yohai, Pfizer and Christoper Jackson, Otsuka Pharmaceutical, Inc.

  

The panelists all specified the importance of planning accordingly, something that seem to be an overall theme of the conference. They reminded the audience that if something looks like a red flag, take action. They also discussed the impact on an organizations resources now that the final rule has been delayed. The panel agreed that the final rule will be a priority for everyone and knowing your portfolio, and the fact that people have the context already will hopefully help to expedite the process once the rule is released.  

They also recommended pulling  together a cross functional group of colleagues. Dissect the rule, what will it change? What operations/legal questions do you have? This will help you realize what you have, and figure out what you need. Everyone weighing in, leaves no room for surprise.

We hope you enjoyed the 2013 MDRP Conference, see you next year!

MDRP 2013: Day 2 Recap (part 2)

The second half of MDRP 2013 Day 2 began with our track sessions, which were split into four segments: Methodology, Finance, State, and Systems. The first session of the Systems track, It's Almost Here - Now What? Operationalizing the AMP Final Rule was led by Marcy Imada, Deloitte and Touche, LLP.

Imada covered the topic that's on everyones mind, the AMP final rule. Her advice? Start by assembling the right team, it's important to keep an open line of communication throughout the entire process. Also, in terms of tackling the uncertainty of the AMP final rule, analyze, prioritize, and implement. It's imparative to analyze all possible outcomes to ensure a smooth transition when the final rule is released, prepare ahead of time! Also, prioritizing will help you save time, as well as stay organized, which are both important components to approaching the final rule.

One of the later afternoon Methodology sessions, Government Pricing Policies & Methodologies --Methodology Foundation of Compliance, was led by John Shakow, King & Spalding. Shakow covered important topics such as, why documentation is a compliance requirement, as well as a practical necessity. He also discussed the elements of a comprehensive set of methodologies, and the best practices.

So why is documentation a compliance requirement? Price reporting methodology documents are always at the top of the list of documents requested from auditors, investigators and prosecutors, that's why it's necessary to keep all documents organized and updated. The legal resources on which we rely to govern pricing reporting are detailed and exacting, but not nearly detailed enough to reliably and consistently guide the calculations. Comprehensive, thoughtful and well-articulated methodological documents are our first defense against allegations of ‘reckless’ treatment in price reporting.

Shakow also reviewed the elements of a comprehensive set of methodologies: product master, price type narratives, inclusion/exclusion schema by price type (transaction type), reasonable assumptions by price type, non-price type methodologies, record of communications with authorities and implementation SOPs/crosswalks to system coding.

Specific Methodology documents are critical tools in coding and testing GP systems. The creation and maintenance of these methodologies is an internal education tool for use by personnel new to GP, the certifier, and all other business related aspects, so if there are any errors it will impact various groups.

Shakow closed with some advice about the final rule. While you're waiting for the final rule, use it as an opportunity to examine, review and tighten methodology documentation, especially because it is highly unlikely the Final Rule will be retrospective in its application.

Stay tuned for our recap of the final day of MDRP!

MDRP 2013: Day 2 Recap (part 1)

Edward McAdam, Daiichi Sankyo kicked off opening remarks for day 2 of MDRP 2013, leading us into our morning Keynotes. 

The first Keynote: Healthcare Policy into 2014 - Medicaid's Downstream Effect on a Financially Struggling United States Government lead by Michael Steele, former Chairman of the Republican National Commitee and Poly Analyst at MSNBC was our first session of the day. Steele asked questions such as, "What are our priorities as a nation?" and reminding the audience to think about what it is you do in the context of a service provider, and service given.

Steele also touched on the future of problem solving, or rather, the problem solvers, millennials, describing their dependency on apps, but also their ability to create new ones to solve problems. Steele's overall message was that you're going to have to adapt to create a new environment, while still dealing with the same old issues, especially with our healthcare system changing so drastically. He closed with asking the audience, how are you going to fit into the future? Steele reminded them that it doesn't matter if you like the ACA or not, it's here, and it's happening. The old rules no longer apply, so you must adapt to the new ones, create new conversations, because our decisions will become the strategic links as to how we solve problems in the future. 

Commander Krista Pedley, Director at the Office of Pharmacy Affairs, kicked off the next session, Annual Update on 340B Program Regulations, Processes and Enforcement Answers from PHS. Pedley discusssed the components that make up the HRSA audits of entities, including volume of purchase, length of program, and targeting entities. She also touched on the process of audit results, noting that entities have opportunity for notice and hearing, and once agreed, the final report is posted to the website. 

Another topic Pedley covered was the purpose of annual recertification, which is required by statute to ensure program intergrity, compliance, transparencey, and accountability. Perhaps one of the biggest benefits from the resertification is the accuracy of covered entity information for 340B data bases that it produces.

The last issue Pedley addressed was the 340B user fee, although some people may not necessarily agree with it, but it's the only way the program can continue to improve and evolve, without the fee there would be no resources for the program.

Our next session, Taxpayer Dollars and Corresponding Oversight Requirements, lead by Alice Valder Curran, Partner at Hogan Lovells LLP, discussed the '340B Program Reconsidered'. She answered the question, program savings or program profit? Stating that program savings is really program profit, if 340B were restricted, manufacturers would get more money. And in terms of protecting the taxpayer- which one are we protecting? 340B saves taxpayers money, aren’t manufacturers taxpayers too? It’s not a question of we are better at where we are, its that we're nowhere near where we need to be. Should 340B discounts be viewed as taxpayer dollars? And if not, why not?

Another topic that Curran covered was entity recertification, more importantly, changing how it's determined. Also asking, should covered entities have any accountability for how they use 2 billion dollars a year?  She also discussed the fact that covered entities face extremely limited penalties in terms of interest and exclusion from programs. Currans bottom line? Stop complaining and start looking into your liabitlity. Start overseeing your exposure to the 340B program, analyze your 340B book of business and gross-to-net impact. GTN has suffered from 'benign neglect' for far too long, and it's time to take a closer look. Also, do your homework now, know the issues important to your company, the mega-rule will be your chance to ensure your concerns are addressed regarding compliance and operational issues. So keep an eye on the legislation this fall and be prepared!

Kathleen Peterson, Special Counsel at Cooley LLP, finished up our morning session with AMPs, NARPs, NADACs and FULs Oh My! Peterson discussed the outcome of the proposed rule. If finalized, it would replace each professional dispensing fee with actual acquisition cost plus professional dispensing fee. Historically, the dispense fee for Medicaid has been primarily low, this would increase the fee substantially. Peterson also discussed the impact of marketplace changes on rebate payments. In closing, she advised to learn from your past, and always evaluate possible legal issues. 

Stay tuned for coverage from our afternoon track sessions!

MDRP 2013: Day 1 Recap

The first morning session for the AMP Final Rule- What it says, What it Means and How to Implement it kicked off today with opening remarks from Alice Valder Curran, Partner at Hogan Lovells LLP. Curran discussed possible dates for the AMP rule, as well as how you should prepare for it. Some of her key takeaways? Read the statute and regulations, and locking in your consulant before the rule is released. Developing a relationship with your consultant early can help you both hit the ground running once the rule is released.

Following Curran was Ven Adamov, Senior Manager for Government Contract Services at Ernst & Young discussing Product Master Issues. Adamov covered issues such as, Product Master Influence on Government Price Reporting, varifying both data uses and organizations, systems changes, and data fragmantation. Also, because every company is different, understanding the field definitions may vary by team. 

Our next session, Authorized Generics and AMP lead by Kave Niksefat and Cynthia Hwang from IMS Health. Niksefat and Hwang covered key questions to answer before including authorized generics in AMP, as well as what makes up an authorized generic. They also discussed how sales and discounts to second manufacturers can be accounted for, and the impact AG will have on Brand AMP.

Rick Zimmer, Partner at KPMG LLP, concluded our morning session with Clarifications to the Bundled Sales Definition. Zimmer discussed the importance of identifying the bundle, as well as self-allocating bundles, and the impact of nestled bundles. 

Before the last networking break of the day, John Shakow, Partner at King & Spalding, presented on, 340B Refund Management and Implications for Reported Price Points. Shakow discussed the impact on CMS pricing when a 340B covered entity attempts to make a repayment arising out of violations of a program prohibition, or losing 340B program eligibility. He ended the session advocating that CMS adopt a helpful rule: "once a 340B sale, always a 340B sale."

Alice Valder Curran, session chair, began one of the last presentations of the day, Independent Pricing Reporting Issues Related to Texas. Curran covered both statutory and regulatoary requirements, as well as trade and calcuation questions and methodology documentation.

The last and final presentation of the day, Preparing for the Final Rule, was lead by Katie Lapins and Clay Willis from Huron Life Sciences. Although there is no definite date, many industry experts believe the final rule will be relased sometime between December and January. So what should you do to prepare? Lapins and Willis suggest educating and coordinating with internal teams in your company, as well as evlauating GP availability to help determine bandwith. They also reccomend documenting all assumptions and modeling potential changes for big areas of your organization.

That concludes day 1 of MDRP 2013, stay tuned for Day 2 updates!

Achieving MDRP compliance while protecting your bottom line

Today's guest post has been provided by Lise Neely, Director of Product Marketing at Revitas

Year after year, the Medicaid Drug Rebate Program (MDRP) Summit brings together government regulators, pharmaceutical executives, and industry leaders to discuss new regulations and best practices for maneuvering through the Medicaid Drug Rebate Program. Compliance is top of mind for many summit attendees, as companies struggle to meet government needs without sacrificing their bottom line.

For organizations to overcome regulatory hurdles in a complex rebate system, they have to extend beyond compliance and incorporate revenue management in their MDRP process. Only then can they ensure their processes are auditable and reportable while maintaining profitability. But actually implementing and evolving such business rules is a struggle for many organizations, especially given ever-shifting regulations.

Achieving perfect MDRP compliance and implementing effective business rules are not easy, but Revitas is leading two presentations addressing best practices for sifting through these processes at the upcoming MDRP Summit. First, Barry Hansen, Product Manager for Revitas Government Pricing, and Michael Panicaro, Manager of Solution Engineering at Revitas, will present “Take a Product through the Rebate System” on September 9 at 4:30 p.m. CDT. They’ll walk through each step of the MDRP process to teach you how to move your product through the MDRP pipeline, from initial claim to validation to disbursement, while avoiding margin erosion and maintaining compliance.

Hansen and Panicaro will also address how to identify and implement business rules within an organization in a presentation titled “Translating Business Rules into System Processing” on September 10 at 3:30 p.m. CDT. In an age of increasingly complex government pricing mandates, business rules develop and evolve through multiple outlets, from federal and state governments to security and system requirements. You’ll learn how to successfully manage the influx of business regulations by understanding the source of business rules, learning how to interpret these rules, and then discovering how they can be expressed as requirements.

We’ll also be exhibiting at booth #23 during the conference, so please stop by if you’d like to hear more!

To learn more about the 18th Annual Medicaid Drug Rebate Program, download the agenda. We hope to see you next week in Chicago!

Maryland launches campaign to help promote new marketplace

Maryland is the latest state to launch a health care campaign using television, radio, and print ads, to help promote, educate, and encourage consumers to sign up for health insurance coverage. The state's new insurance marketplace, The Maryland Health Connection, opens October first and will allow residents to compare plans, and also help them determine their eligibility for subsidies.

The state is spending $2.5 million on the campaign through the end of 2014, and hopes to attract nearly 300,000 people to buy health insurance or sign up for expanded government coverage over that time. Health officials said they expected the ads to be an efficient and effective method to educate state residents about the opportunities in a way that grabs their attention and is understandable.

Do you think advertisements will be the most effective way to promote the new marketplace?

Want to learn more about the future of the marketplace? At IIR's HIX Reloaded, we'll help you shape your strategy for the ever evolving marketplace. Crowdsource the agenda by voting on what you need to know to ensure success when coverage starts on January 1, 2014.

To learn more, download our agenda. As a reader of this blog you'll receive 15% off the standard rate when you use code XP1810BLOG to register. We hope to see you November 14-16 in Baltimore, MD!

Last Chance To Register For MDRP!

There is still time left to register for the 18th Annual Medicaid Drug Rebate Program Summit! Online registration closes this Sunday, September 8th, use code XP1858LINK to save 15% when you register!

Are you ready? MDRP 2013 is THE authoritative event for everything government pricing, rebates and regulation. Join 60+ speakers, 500+ MDRP executives, 20+ solution providers in the only event where the government programs and pricing industry comes together each year to debate and create a roadmap to operational solutions.

Don't miss out on these key highlights on the MDRP 2013 agenda:

• New for 2013! Pharmaceutical VA Contracting and Compliance Summit

• Direct access to State Rebating Representatives in State Dispute Resolution Meetings

Four jam-packed session tracks:

• Overcome Challenges to Medicaid Drug Rebating Methodology to avoid costly calculation mistakes that affect company financials

• Financial Implications to Government Pricing Programs to establish connections between the departments affected by government pricing programs

• Understand and Comply with State Processes, Operations and Requirements to sustain positive relationships with the states and avoid disputes

• Contract Management, Business Analytics and Systems Implementation updates to ensure you have the latest methods that will lead to the most accurate calculations and rebates

To learn more, download our brochure. Questions about the event? Feel free to contact Kate Devery at kdevery@iirusa.com or visit the webpage.

Sincerely,
The MDRP Team

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P.S. - You can find the most up-to-date hotels that have availability and current rates near our host hotel here.

Register today for our HIX Webinar: Identifying and Engaging Stakeholders in Health Reform Outreach

Approximately half of people eligible for health insurance exchanges don't know what exchanges are, or that they're eligible. With enrollment beginning on October 1, it's all hands on deck to educate consumers on exchanges and how to enroll. The government and health plans are working together for this effort, and one of the most successful ways to connect with potential enrollees is to work with community based organizations that have established trust with members of the community. This includes working with faith-based groups, local libraries, health care, behavioral health, and human service providers, and many other groups who have contact with potentially eligible enrollees.

DATE: September 18, 2013 TIME: 2:00PM-3:00PM EST

SPEAKER:  John Lovelace, President, Government Programs and Individual Advantage, UPMC Health Plan

Mr. Lovelace is President of UPMC for You, a managed care organization that serves Medical Assistance and Medicare Advantage Special Needs Plan recipients in 40 counties in Pennsylvania.

COST: Complimentary

This webinar will cover strategies to:
• Increase awareness of the general public in regards to health insurance marketplaces
• Develop understanding of how the Health Insurance Marketplace will work in your state(s)
• Identify what information consumers need in order to make informed decisions
• Understand the role of Navigators, Certified Applications Counselors and others who can assist consumers in enrollment

And more!

Space is limited, reserve your seat today!

Want to learn more about this year’s HIX Reloaded event? Download our agenda. As a reader of this blog, mention code XP1810BLOG when registering to save 15% off of the standard rate. Questions? Feel free to email Kate Devery (KDevery@IIRUSA.com) or visit our homepage.

We look forward to seeing you November 14-15 in Baltimore, MD!

Cheers,
The HIX Reloaded Team

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P.S. – Don’t forget to vote for the 2013 HIX Reloaded Agenda Topics!

Overcome Challenges to Medicaid Drug Rebating Methodology

We're pleased to announce a new content partnership Huron Life Sciences. Each week they'll be sharing their latest insights on the Medicaid Rebate Process, Government Pricing & much more. Want to join them at this year's Medicaid Drug Rebate Program taking place September 9-11 in Chicago, IL? Save 15% when you mention XP1858BLOG to register. Today’s Author: Keren Isaacson
 With the AMP Final Rule looming in January, IIR’s MDRP Summit is the place to be for all things Government Pricing. On Tuesday afternoon, the conference offers four dynamic tracks for attendees. Track 1, “Overcome Challenges to Medicaid Drug Rebating Methodology,” is dedicated to some of the current “hot topics” in the GP world, especially with regards to your overall methodology. John Shakow from King and Spalding is speaking on “Government Pricing Policies and Methodologies – The Foundation of Compliance,” that will look at what documentation manufacturers should be maintaining to ensure they are compliant. John will discuss best practices for format, scope, depth, updating, supporting materials and reasonable assumptions documentation.

In this age of mergers, acquisitions, and divestitures, there are two sessions of note in this track: “Understand Company Needs When Acquiring an Authorized Generic” and “Plan for the Effects of Acquiring or Divesting a Product or Company,” which includes a panel discussion. There are always unanticipated issues that arise when a company undertakes an acquisition and both sessions will address the questions to keep in mind if you’re faced with this situation, including: What calculation methodology should be used if an acquired product has a special set of requirements? How can a manufacturer best handle calculation methodologies that differ across the organization?

And who doesn’t learn from a Case Study? David Buckley from GlaxoSmithKline will share one manufacturer’s experience in using state reported data to help eliminate URA issues/errors, including communication tips for internal and external stakeholders.

Bringing together participants from all across the industry, and providing the opportunity to network with industry experts as well as representatives from over 100 companies, including Huron Consulting Group, IIR’s MDRP Summit is a one stop shop for answering many of your GP questions. It is an exciting time in our industry and participation in the event will no doubt bring ideas to help resolve many GP challenges.